Officer -Executive

Key Responsibilities

Validation Strategy & Documentation

• Prepare comprehensive validation

  protocols, reports, and master plans

  for various dosage forms including OSD, oral liquids, and topical formulations.
• Define

  validation strategy

  in line with current regulatory expectations and industry best practices (e.g., FDA, EMA, WHO).
• Implement a

  life cycle approach

  to validation covering development, execution, monitoring, and revalidation.

Cleaning Validation

• Execute and oversee

  cleaning validation activities

  .
• Select worst-case products based on matrixing, carry out swab and rinse sampling.
• Design and validate

  sampling plans

  , calculate MACO, and determine acceptance criteria.
• Prepare and review cleaning validation protocols and reports.

Process Validation

• Conduct

  process validation (PV)

  for new and existing products.
• Draft and execute validation protocols including BMR/BPR reviews.
• Participate in risk assessments (e.g., FMEA) and root cause analysis as needed.

Equipment & Utility Qualification

• Prepare and execute protocols for

  Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ)

  .
• Perform

  equipment and utility qualifications

  (HVAC, purified water systems, compressed air, etc.).

Hold Time Studies

• Plan and execute

  hold time studies

  for bulk, intermediate, and finished products.
• Analyze data and compile reports in accordance with regulatory expectations.

Sampling Plan & Worst Case Matrixing

• Design effective

  sampling plans

  based on worst-case scenarios, product complexity, and manufacturing practices.
• Perform

  matrix selection

  for cleaning and process validation.

Compilation & Compliance

• Ensure end-to-end

  compilation of validation documentation

  in compliance with cGMP.
• Participate in internal/external audits and provide technical support during regulatory inspections.

Required Qualifications

• Bachelor's / Master's Degree in Pharmacy, Pharmaceutical Sciences, or a related field.
• Minimum 5 years of experience in

  validation within formulation development

  (OSD, oral liquids, topical).
• Sound knowledge of

  regulatory guidelines

  (USFDA, MHRA, EMA, WHO, etc.).